Unique Device Identification
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Transcript of Unique Device Identification
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Unique Device Identification
Jay CrowleySenior Advisor for Patient Safety
Food and Drug [email protected]
301-980-1936
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Current Device Identification• Non-standard device identification systems; standards
used in different ways• Not necessary unique or unambiguous• Does not include all necessary levels of uniqueness• Manufacturers’ own number/catalogue number• Distributors’ – apply different, proprietary number; lot
or serial number not captured• Hospital – yet different identification number/code
• Information on use not usually captured• Control numbers rarely captured
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Future Device IdentificationDevelop a system to identify medical devices, which is:• Consistent• Unambiguous (differentiates among all dimensions)• Standardized• Unique at all levels of packaging• Harmonized internationally
And facilitates the:• Storage, • Exchange, and • Integration of data and systems
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UDI brings… Global Visibility• Medical device recalls• Adverse event reporting and postmarket surveillance• Tracking and tracing, supply chain security; and anti-
counterfeiting/diversion (location systems)• Comparative effectiveness (e.g., registries)• Disaster/terror preparation and shortages/substitutions• Reduce medical errors• Documenting medical device use in patient’s
EHR/PHR, hospital information systems, claims data• Sentinel Initiative - strengthening FDA’s ability to
query data systems for relevant device information
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FDA Amendments Act of 2007September 27, 2007, the FDAAA signed into law:
The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.
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GHTF UDI ADWG• Formed October 2008• EC Chair (Laurent Selles)• Members US (FDA, AdvaMed), Europe (EC, Eucomed,
EDMA), Japan, Canada• AHWP recently joined (China)• Washington April 2010; Brussels June 2010; Ottawa
September 2010• Guidance submitted to Nov 2010 SC meeting• Public Document – available at:
http://www.ghtf.org/ahwg/ahwg-proposed.htmlComments due by 30 April 2011.
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Establishing a UDI System Combination of 4 distinct steps:1. Develop a standardized system to develop the
unique device identifiers (UDI)2. Place the UDI in human readable and/or AutoID on
a device, its label, or both3. Create and maintain the UDI Database4. Adoption and Implementation
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1st – Developing the UDI• Develop UDI code according to ISO 15459 [GS1,
HIBCC]• Created and maintained by the manufacturer• Concatenating Device and Production Identifier• Device Identifier (DI): [static] Manufacturer, make,
model [i.e., each catalogue number]• Production Identifier (PI): [dynamic] however
product is currently controlled – serial, lot number; expiration, manufacturing date
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2nd – UDI Application• Unique UDI applied to all levels of packaging,
down to the lowest level (patient use/ unit of use)• Human readable and/or encoded in a form of
automatic identification technology• No specific technology would be identified
(technology neutral)• Identify a series of standards (linear barcode, 2-
dimensional barcode, RFID)• Direct Part Marking (DPM) for some devices
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UDI Application Example
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UDI Application Example
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UDI Application Example
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Combination Products and KitsLike other devices – intended to facilitate identification:• Combination product (device) has its own UDI; each
device should have its own UDI.• Each kit (devices only) has its own UDI; each device
in a kit should also have its own UDI.
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3rd – Global UDI Database• Device Identifier Type/Code [GTIN, HIBCC]• Make/model; Brand/Trade Name; Size; Description• Device model number (or reference number)• Unit of Measure/Packaging level/quantity• Controlled by – Lot and/or Serial Number; Exp. Date• Contact name, phone, email• GMDN Classification code/term• Storage condition; Single Use; Sterility• Contains known, labeled allergen (e.g., latex)• FDA premarket authorization (510k, PMA)• FDA Listing Number
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FDA’s UDI Database
Distribution
Web based tool
BusinessRules
Manufacturer(Acme)
GSI GDSN
The label of Medical Device 123 Size 45:Device Identifier (Device XYZ123)Production Identifier (Lot #ABC)Expiration date (MMDDYYYY)
Sterile; Latex free
Bulk HL7 SPL
Minimum Data SetFor each Device Identifier:• Manufacturer and model• GMDN Code• Other attributes
or
or
FDA’s UDIDatabase
FDA
FDA Managed
Public User Interface
HL7 SPL
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Implementation• Based on premarket risk class:
• class III – 12 months after final rule• class II – 36 months after final rule• class I – 60 months after final rule
• Allows stakeholders to jointly learn and for mid-course corrections
• Phase out national numbering system (NDC/NHRIC)• Robust alternate placement and exception process• Expect manufacturers and groups of manufacturers to
submit requests – results of which will posted.
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4th – Adoption and Implementation• Facilitate distributor uptake and use• Facilitate hospital uptake and use• Facilitate use of UDI throughout device lifecycle• Drive integration – MMIS-Clinical• Drive appropriate use of UDI in EHRs – and use of
EHRs for registries and other postmarket activities
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UDI Database Pilots• Phase 3 – Purpose: Assess the feasibility of collecting,
storing, and retrieving UDI data from initial creation (manufacturer) to point of use (hospital) .
• Phase 4 – Purpose: Assess how UDI data will impact FDA device information use in current systems
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Unique Device Identificationwww.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
UniqueDeviceIdentifiers
Email: [email protected]